- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Biologics Evaluation and Research
We, FDA, are issuing this guidance to provide you1 with recommendations for testing donations of Whole Blood and blood components for West Nile Virus (WNV) using an FDA-licensed donor screening assay2 . We believe that the use of a licensed nucleic acid test (NAT) will reduce the risk of transmission of WNV, and therefore recommend that you use a licensed to screen donors of Whole Blood and blood components intended for transfusion for infection with WNV.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2008-D-0263.